UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION
`
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`
`Patent Owner
`
`
`
`
`IPR2017-01295
`Patent 8,709,062
`
`
`
`
`DECLARATION OF THOMAS TROTTA
`IN SUPPORT OF EDWARDS LIFESCIENCES CORPORATION’S
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT 8,709,062
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 1
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`EDWARDS LIFESCIENCES CORPORATION
`
`Petitioner
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.
`
`Patent Owner
`
`
`
`
`IPR2017-01295
`Patent 8,709,062
`
`
`
`
`DECLARATION OF THOMAS TROTTA
`IN SUPPORT OF EDWARDS LIFESCIENCES CORPORATION’S
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT 8,709,062
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 1
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
`TABLE OF CONTENTS
`
`Page
`
`Background and Qualifications ....................................................................... 1
`
`
`
`
`I.
`
`II.
`
`Assignment and Materials Reviewed ............................................................ 16
`
`III. Overview of the ’062 Patent and Background of the
`Technology .................................................................................................... 18
`
`A.
`
`Scope and Content of the Art Before August 23, 1996 ...................... 18
`
`1.
`
`2.
`
`3.
`
`History of Angioplasty and Stents ............................................ 18
`
`Stent Delivery System Design Considerations ......................... 24
`
`Balloon-Expandable Stents Had Known
`Advantages and Design Challenges Compared to
`Self-Expanding Stents ............................................................... 29
`
`Summary of the ’062 Patent ................................................................ 35
`
`Claims at Issue ..................................................................................... 37
`
`1.
`
`Independent Claims 1, 13, 21, and 26 ....................................... 37
`
`B.
`
`C.
`
`D.
`
`Relevant Prosecution History .............................................................. 46
`
`IV. Person of Ordinary Skill in the Art ................................................................ 51
`
`V.
`
`Claim Construction ........................................................................................ 52
`
`VI.
`
`Invalidity Analysis ......................................................................................... 53
`
`A.
`
`B.
`
`Scope and Content of the Prior Art ..................................................... 56
`
`Specific Grounds for Unpatentability and Invalidity .......................... 58
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 2
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
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`1.
`
`2.
`
`3.
`
`Ground 1: Claims 1-26 are Obvious Over Fischell
`’274 in View of Burton, and in Further View of
`Knowledge of a POSITA and/or Sugiyama ’032 ..................... 58
`
`Ground 2: Claims 1-26 are Obvious Over
`Sugiyama ’032 in View of Fischell ’507, in
`Further View of Jendersee ........................................................ 89
`
`Ground 3: Claims 1-7, 9-15, 17-21, and 23-26 are
`Obvious over Rupp in View of the Knowledge of a
`POSITA and/or Sugiyama ’032 and in Further
`View of Jendersee ...................................................................125
`
`VII. Conclusion ...................................................................................................149
`
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 3
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`
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`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
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`I, Thomas Trotta, hereby declare and state as follows:
`
`
`1.
`
`I have been retained as an expert witness by Edwards Lifesciences
`
`Corporation (“Edwards”) to provide my expert opinions relating to the validity of
`
`certain claims of U.S. Patent No. 8,709,062 (“the ’062 Patent”) owned by Boston
`
`Scientific SciMed, Inc. I make this declaration based upon my personal
`
`knowledge, skill, experience, training and education and upon information I have
`
`reviewed in connection with my retention by Edwards, which is described below. I
`
`am not and have never been an employee of Edwards or any affiliate or subsidiary
`
`thereof. Although Edwards is compensating me on this engagement at the rate of
`
`$250 per hour, I have no stake in, nor does my compensation depend in any way
`
`on, the outcome of any proceeding relating to this patent.
`
`
`2.
`
`The following constitutes facts I know of my own knowledge and my
`
`own opinions. If called as a witness, I could and would testify competently
`
`thereto.
`
`I.
`
`Background and Qualifications
` My experience with minimal invasive coronary catheters began when
`3.
`
`I was hired by Cordis Corporation in 1982. At that time and through the 1990s,
`
`Cordis focused on research and development and became a leading innovator and
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 4
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`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
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`major manufacturer of catheters, balloons and stents used to treat circulatory
`
`problems, including angioplasty.
`
` My first position at Cordis was as an extrusion engineer. Soon after I
`4.
`
`joined the company, however, my role expanded to include engineering issues
`
`relating to many other manufacturing processes related to production of Cordis’s
`
`angiography devices. In 1988, I transferred out of manufacturing and into the
`
`Polymer Research and Development group, where I participated in and led various
`
`projects related to the development of balloons and catheters for use in
`
`percutaneous transluminal coronary angioplasty (“PCTA”). In 1996, Cordis was
`
`purchased by Johnson & Johnson. I remained at the company as an Engineering
`
`Fellow, assisting in the development of new catheter and balloon catheter products
`
`until 2008. In 2008, I formed my own engineering consulting firm. Although I no
`
`longer do so, I have over the past several years consulted with and worked for, in
`
`particular, Cordis (as a division of Johnson & Johnson).
`
`
`5.
`
`Over more than thirty years in this field, I have either worked on,
`
`helped devise, or assisted in troubleshooting every Cordis process used to
`
`manufacture PTCA catheters and every PTCA stent delivery systems Cordis has
`
`produced. The areas in which I have been involved include, but are not limited to:
`
`• Manufacture of components,
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`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
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`• Attaching hubs and balloons to the shafts,
`• Shaft material selection and attachment methods,
`• Folding of the balloon,
`• Metal marker bands used to locate the balloon working
`length,
`• Protective tubing for the balloon during shipment,
`• Stent attachment to PTCA balloons,
`• Hub materials and securement processes,
`• Thermoforming of various components used in the
`construction,
`• Selection of polymers and processes for all components.
`I am a named inventor of thirty-three patents, of which twenty-eight
`
`
`6.
`
`address discoveries and improvements pertaining to balloon catheters and/or stent
`
`delivery systems. Attached as Exhibits 1004 and 1005 are a copy my curriculum
`
`vitae and a list of my patents.
`
`
`7.
`
`During my more than thirty years with Cordis and Johnson &
`
`Johnson, sometimes working alone and sometimes in collaboration with others, I
`
`devised and developed many improvements to angiography and angioplasty
`
`devices. Some of these improvements were of such importance that competitors
`
`ultimately had to copy the technology in order to succeed in the market. To my
`
`knowledge, some of the improvements in balloon catheter and stent delivery
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 6
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`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
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`technology to which I contributed at Cordis and Johnson & Johnson are still used
`
`today in all PTCA devices in the market.
`
`
`8.
`
`At some point in the 1990s, the CEO of Cordis asked that I support
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`outside and internal attorneys defending Cordis’ patents in litigation. At the time,
`
`he told me that the corporation’s very existence depended on our being able to
`
`protect our innovations from infringers. This additional role involved me in more
`
`than twenty years of litigation. A majority of the patents on which I was a named
`
`inventor were eventually either amicably licensed to other medical device
`
`companies or involved in patent enforcement litigation. I testified about the
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`technologies addressed by the Cordis patents in over eight separate litigations.
`
`
`9.
`
`In 2008, the company asked me to move from Florida to New Jersey.
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`I chose instead to retire from Cordis and become a private consultant.
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`Subsequently, Cordis became one of my clients. My consulting for Cordis evolved
`
`into a casual, part time Senior Engineering Fellow position. When Cordis was sold
`
`to Cardinal Health in October 2015, Cardinal Health also offered me a consulting
`
`position. One reason these positions were extended to me was because I was and
`
`am the only person with knowledge of all the processes and reasoning behind these
`
`processes and material selections for balloon catheters, not only within Cordis but
`
`across the industry. Throughout my career at Cordis (including when it was part of
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`Petition for Inter Partes Review
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`J&J or Cardinal Health), I had to keep abreast of new materials and techniques
`
`from competing manufacturers as well as physicians to lead R&D for balloon
`
`catheters. I am therefore intimately familiar with the state of the art in this area.
`
` One development project in which I was involved seems particularly
`10.
`
`relevant to the ’062 patent. Prior to 1988, Cordis had been developing PTCA
`
`catheters using polyester materials. Soon after I joined the R&D department, I was
`
`assigned to a program to research the suitability of other polymers for PCTA and
`
`to develop balloon and catheter designs using these alternatives.
`
` Before proceeding, I should provide some nomenclature. In medical
`11.
`
`terms, “distal” means farther from a reference point and “proximal” means closer.
`
`In the case of catheters, the reference point is the hub that is handled by the
`
`physician. Thus, the distal end of the catheter is the end farthest from the
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`physician and proximal refers to anything closer to the physician. PTCA is a
`
`procedure for opening up an occluded coronary artery. In this procedure, a balloon
`
`is mounted on the catheter shafts and is tightly wrapped or folded around the inner
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`shaft. This deflated balloon on a catheter is fed from an entry point into a major
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`artery such as the femoral artery, through the patient’s circulatory system, to the
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`point of occlusion. Radiopaque markers on the balloon section of the catheter help
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`the physician locate the balloon, and guide it to the treatment area. At the
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`Petition for Inter Partes Review
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`treatment area, the balloon is then inflated to expand the narrowed portion of the
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`artery.
`
` The terms “trackability” and “flexibility” frequently appear in
`12.
`
`reference to catheter design. These concepts are related, but refer to different
`
`performance attributes.
`
`
`13.
`
`“Flexibility” of plastic is the force required to bend a sample. The
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`distal end of an angioplasty device to be inserted in the tortuous coronary arteries
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`requires a certain flexibility, to successfully navigate to the site of the restriction.
`
`However, an overly flexible distal portion cannot be pushed to the targeted
`
`restriction within the artery. I have included an illustration of a catheter stiffness
`
`tester as Exhibit B to this declaration (Gurley Precision Instruments – Physical
`
`Testing Equipment) .
`
`
`14.
`
`“Trackability” refers to the force that is required to push an
`
`angioplasty device over a guidewire to the site of the restriction in a coronary
`
`artery. Trackability is a function of several variables including flexibility, friction,
`
`diameter, and profile. Trackability was measured at Cordis with a model of arterial
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`tortuosity. A guidewire was inserted in the model and fixed. The catheter was
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`advanced through the model over the guidewire and the force needed to advance
`
`the catheter was measured.
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 9
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`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
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` When a PTCA balloon catheter is inflated to the desired size, the
`15.
`
`balloon consists of a working length of constant diameter and a transition cone
`
`region on each side of the working length that tapers to a leg at each end of the
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`balloon. In the most common design, the leg on the distal side joins to the inner
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`shaft of the catheter; the leg on the other, proximal end is fixed to a pressure
`
`resistant tube that constitutes the outer shaft of the catheter. I provide an annotated
`
`figure from one of Cordis’s patents below to illustrate these parts of the balloon
`
`and catheter. While the balloon is being fed to the treatment site, it is deflated and
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`compressed into the minimum diameter package possible. We refer to the balloon
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`in this state as being “compressed.”
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 10
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`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
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`Annotated Figure 1 from U.S. Patent 5,853,389
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`
`
`The balloon in a PCTA balloon catheter is axially stretched and blown from a
`
`parison in a manner similar to the process used to construct soda bottles. The
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`Cordis team pursuing the polyester based PTCA catheter used polyethylene
`
`terephthalate (PET) as the balloon material. Later, we developed a polyamide
`
`balloon for our PTCA catheter. Although the polyamide balloons had exceptional
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`strength, flexibility and other advantageous properties, our initial design had an
`
`abrupt change in diameter (a bump) at the interface of the distal leg portion and the
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`distal cone. This produced a higher profile and an abrupt change in profile which
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`we realized would inhibit the ability of the physician to direct the compressed
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`balloon to the treatment site
`
`
`16.
`
`I revised the processing procedure to include a stretch-blow-stretch-
`
`blow (SBSB) process. The revised procedure completely eliminated the bump. I
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`presented an SBSB balloon at a R&D meeting. It was obvious to all that this
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`dilatation balloon was superior to existing commercial designs. The R&D Director
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`instructed us to produce a catheter based on polyamides and to build production
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`balloon equipment designed to the new process.
`
` The catheter shafts of the polyamide Cordis angioplasty catheter were
`17.
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`made of medical plastic compounds. The outer shaft of Cordis catheters required
`
`five properties: High hoop strength to resist the pressures generated to inflate the
`
`balloon; flexibility to allow low forces to negotiate tortious vessel paths; a thin
`
`wall to reduce profile; an acceptable failure mode; and chemical properties that
`
`allowed the proximal sleeve to be attached to the balloon thermally. The material
`
`used is popularly classified as a polyamide elastomer. The one used for Cordis
`
`devices was polyetheramide.
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` The inner shaft of Cordis’ PTCA Cordis angioplasty catheters was a
`18.
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`coextruded tube, which could be an extrusion with two layers, see U.S. Patent
`
`5,538,510. The inner layer was made of High Density Polyethylene (HDPE) to
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`provide low frictional properties and an outer layer of polyamide elastomer to
`
`provide a suitable chemistry to thermal bond the distal sleeve of the polyamide
`
`balloon. During the two-layer extrusion process an additive to the HDPE
`
`promoted bonding between the layers. The inner shaft required similar properties
`
`as the outer shaft except: high hoop strength and an acceptable failure mode.
`
` Cordis went forward with the polyamide balloon PCTA design and
`19.
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`process and discontinued the polyester development. We brought our PTCA
`
`system to market a few years later. Eventually, Cordis sold millions of polyamide
`
`PTCA dilatation balloons based on our work in the late 80s.
`
` Restenosis is the reduction in the opening of a coronary artery that
`20.
`
`often occurs after angioplasty. Drs. Julio Palmaz and Richard Schatz invented a
`
`solution to this problem by developing a laser cut stainless steel tube (stent) that
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`could be implanted in a blood vessel by expanding with an angioplasty balloon.
`
`They filed for a U.S. patent in 1985 (issued as U.S. Patent No. 4,733,665 in 1988,
`
`hereinafter referred to as “Palmaz” or “Ex. 1008”). Johnson and Johnson (“J&J)
`
`purchased certain rights to this innovation, commercialized this device, and gained
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`FDA approval in August 1995. Their product was highly successful with 100,000
`
`uses during 1996.
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` The cut pattern of the first-generation J&J stent was similar to Fig.2A
`21.
`
`above and the expanded stent to similar to Fig. 2B.
`
`
`22.
`
`J&J purchased Cordis in 1996 and merged their stent products with
`
`Cordis’ large portfolio of minimally invasive products. The stent and stent
`
`delivery system soon became a focus for Cordis.
`
` The existing J&J stent system consisted of a stent mounted on an
`23.
`
`existing J&J angioplasty catheter. The stent was secured to the angioplasty
`
`catheter by crimping the stent to the balloon by machine or by hand, then applying
`
`a sheath over the stent. The user retracted the sheath before expanding the stent
`
`with the balloon. The sheath was successful in retaining the stent to the balloon
`
`until the point of delivery. The sheath, however, added to the profile of the system
`
`and required the operator to perform an additional step, retracting the sheath,
`
`during the procedure. This increased profile of the catheter added by the outer
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`sheath is shown below in the annotated Figure 3 of Palmaz below. (See Ex. 1008.)
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` The original J&J catheter also had a low-pressure balloon, which was
`24.
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`unable to exert enough force to perform direct stenting (i.e., simultaneously
`
`dilating the vessel and delivering the stent by inflating the balloon). Thus, a
`
`separate PTCA catheter had to be used to perform the angioplasty in yet another
`
`operation before the original J&J catheter could be used to deploy the stent.
`
` These drawbacks of the original J&J catheter increased the procedural
`25.
`
`time and required a larger diameter guide catheter. The procedure using the
`
`original J&J catheter-based stent delivery system required the physicians to:
`
`a.
`
`b.
`
`c.
`
`d.
`
`guide an angioplasty balloon to the site;
`
`dilate the restriction;
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`retract the angioplasty balloon catheter;
`
`guide the stent delivery system to the restriction;
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`e.
`
`f.
`
`g.
`
`inflate the stent;
`
`retract the stent delivery system;
`
`in many cases, guide another higher pressure angioplasty
`
`balloon to the stent to apply additional pressure to secure
`
`the deployed stent.
`
` An ideal delivery system would allow for direct stenting. A system
`26.
`
`with a lower profile and a higher-pressure balloon without a sheath covering the
`
`stent would allow the physicians to guide the stent into position inflate the balloon
`
`with a higher pressure, if needed; then retract the system. This would greatly
`
`reduce the time, cost of devices; and increased patient safety.
`
` Cordis R&D activities after the J&J merger eventually included
`27.
`
`modification to the stent design and the delivery system, to allow direct stenting . I
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`maintained my position as the leader of the Materials Research and Development
`
`Department. We were tasked with developing a better method to attach next
`
`generation stents to existing Cordis PTCA balloon catheters. When we started this
`
`project, management initially decided to keep the sheath system to reassure the
`
`physicians that the stent would be secured to the balloon until expansion. I
`
`developed a much thinner sheath that was easier to remove from the stent.
`
`However, a sheath-less delivery system would produce an improvement over the
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`sheath system by reducing the profile of the delivery system, and improving its
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`flexibility and trackability.
`
` Our project started by examining a J&J stent and delivery device that
`28.
`
`was ready for shipment. We noticed that the balloon had expanded slightly and
`
`was larger than before ethylene oxide sterilization adding a degree of retention of
`
`the stent to the balloon. The ethylene oxide sterilization included a step of
`
`applying a temperature of 550C +/- 50C to the product. We decided to develop a
`
`process in parallel to the sheath design program, to secure the stent to the balloon
`
`by encapsulating the stent with the balloon material. The idea was to contain the
`
`balloon with the mounted stent in a tube; inflate the balloon; then apply heat and
`
`pressure. After experimenting with the amount of containment, heat and pressure
`
`we found the balloon “encapsulated” the stent and increased the force required to
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`move the stent relative to the balloon. This method was refined and we
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`successfully developed the tooling and process for production. We convinced
`
`management that a sheath-less delivery would provide needed retention and our
`
`process was added to the project plan. I, and a colleague that worked under my
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`direction, won the Johnson and Johnson’s Phillip B Hoffman Award Research
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`Scientist for designing and implementing this process.
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` Stent retention required additional improvements over the years with
`29.
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`different stent and delivery system designs. The stent designs varied with the type
`
`of patterns laser cut into the stainless steel tubing, as seen above in Fig. 2A of
`
`Palmaz. In 2010 when I returned to Cordis as a casual part-time Senior
`
`Engineering Fellow I led a group working on the retention of a new stent design,
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`with significantly reduced opening within the unexpanded stent, to an angioplasty
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`balloon. We found during this project the smaller the openings in the body of the
`
`stent the lower the retention values. This led us to conclude that the region of
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`balloon material expanded outside the stent would not provide sufficient
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`securement to meet our requirements. The amount of balloon material that filled
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`the openings inside the stent had a greater control of the retention than the diameter
`
`of the balloon outside the stent.
`
`II.
`
` Assignment and Materials Reviewed
`
`30.
`
`I have been asked to provide certain opinions relating to the
`
`patentability of claims of the ’062 Patent. Specifically, I have been asked to
`
`provide my opinion regarding (i) the level of ordinary skill in the art to which the
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`’062 Patent pertains, and (ii) the patentability of claims 1-26 of the ’062 Patent
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`(“claims-at-issue”).
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 19
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`Petition for Inter Partes Review
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` The opinions expressed in this declaration are not exhaustive of my
`31.
`
`opinions on the patentability of the claims-at-issue. Therefore, the fact that I do
`
`not address a particular point should not be understood to indicate any agreement
`
`on my part that any claim otherwise complies with the patentability requirements.
`
`
`32.
`
`In forming my opinions I have reviewed the following:
`
`a.
`
`b.
`
`c.
`
`d.
`
`The ’062 Patent (Ex. 1001).
`
`The prosecution history for the ’062 Patent. (Ex. 1002.)
`
`The prior art references discussed in the prosecution
`history of the ’062 Patent, and
`
`The following prior art references:
`•
`
`U.S. Patent No. 4,994,032, filed on November 29, 1988
`and issued on February 19, 1991 (“Sugiyama ’032”) (Ex.
`1009).
`
`•
`
`•
`
`•
`
`•
`
`•
`
`U.S. Patent No. 4,768,507, filed on August 31, 1987 and
`issued on September 6, 1988 (“Fischell ’507”) (Ex.
`1010).
`
`U.S. Patent No. 5,639,274, filed on June 2, 1995 and
`issued on June 17, 1997 (“Fischell ’274”) (Ex. 1013).
`
`U.S. Patent No. 5,026,377, filed on August 17, 1990 and
`issued on June 25, 1991 (“Burton”) (Ex. 1014).
`
`U.S. Patent No. 5,702,418, filed on September 12, 1995
`and issued on December 30, 1997 (“Ravenscroft”)(Ex.
`1017).
`
`Additional references identified in Exhibit A.
`
`- 17 -
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 20
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
`I have also reviewed the other exhibits to Edwards’ Petition for IPR of the ’062
`
`Patent.
`
`III. Overview of the ’062 Patent and Background of the Technology
`A.
`Scope and Content of the Art Before August 23, 1996
`1. History of Angioplasty and Stents
` The ’062 Patent relates to a stent delivery system that uses a catheter
`
`
`33.
`
`with a balloon to deliver and expand a balloon-expandable stent. As reflected in
`
`my work at Cordis described above, the use of balloon catheters and stents in the
`
`human body for repairing vessels such as coronary arteries was well known in the
`
`prior art since at least the 1980s.
`
` Starting in the 1980s, surgeons began using the PTCA procedure I
`34.
`
`described above to treat atherosclerosis and other forms of coronary narrowing.
`
`The Cordis catheter I referenced above is one example of a typical PTCA catheter.
`
`Another typical PTCA catheter as disclosed by U.S. Patent No. 4,964,853
`
`(“Sugiyama ’853”)(Ex. 1011) is shown below.
`
`- 18 -
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 21
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
`
`
` This catheter features an inner tube 1 surrounded by an outer tube 2
`35.
`
`“disposed coaxially with the inner tube 1.” (See generally Ex. 1011, Sugiyama
`
`’853 at 2:59-3:11.) This is a common catheter design that is known as a “coaxial
`
`catheter,” since the inner tube 1 is coaxial with outer tube 2. These coaxial tubes
`
`are made of relatively flexible plastics such as polyethylene or polyurethane. (Id.
`
`at 3:59-65, 5:3-10.) A balloon or other “contractible or foldable expansible
`
`member” 3 is attached at its distal or tip end 7 to the inner tube 1, and attached at
`
`its proximal or base end 8 to outer tube 2. The cylindrical portion of this balloon,
`
`or “working length” is labeled 3a, and has two radiopaque marker bands 14 at its
`
`ends to allow the user to confirm the position of balloon 3 using X-ray imaging
`
`while the catheter is inserted into the body. (Id. at 6:21-31.)
`
`- 19 -
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 22
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
` Although PTCA was an effective procedure for treating narrowed
`36.
`
`blood vessels, post-operative complications could occur. One of these
`
`complications was “restenosis,” where the vessel would close back down to a
`
`narrower diameter, thus requiring a repeat PTCA procedure or further surgery.
`
`(See Ex. 1012, Sigwart et al., “Intravascular stents to prevent occlusion and
`
`restenosis after transluminal angioplasty,” The New England Journal of Medicine,
`
`Vol. 316, No. 12, March 19, 1987, at 701 (“Sigwart”); Ex. 1008, Palmaz at 2:39-
`
`63; Ex. 1010, U.S. Patent No. 4,768,507 (“Fischell ’507”) at 1:20-24, Figs. 1A-1C
`
`(illustrating angioplasty and restenosis).) Over time, surgeons developed the
`
`implantable, expandable “stent” to prevent restenosis and other complications,
`
`starting from a non-expanding coil spring stent which was experimentally
`
`implanted in dogs in 1969. (Ex. 1010, Fischell ’507 at 1:28-38.) By 1987,
`
`researchers understood that “intravascular stents may provide a useful approach to
`
`preventing both acute occlusion and late restenosis” in human patients. (Ex. 1012,
`
`Sigwart at 701; Ex. 1008, Palmaz at 2:64-3:17.)
`
`37.
`
` As I noted above, Drs. Julio Palmaz and Richard Schatz developed a
`
`stent that could be implanted in a blood vessel by expanding with an angioplasty
`
`balloon. They obtained a patent on this stent, and its delivery catheter in 1988, and
`
`gained FDA approval for this device in August 1995. Another balloon-expandable
`
`- 20 -
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 23
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
`stent, the Gianturco-Roubin stent, was developed and commercialized around the
`
`same time. I attach documentation of this stent as Exhibit C to this declaration.
`
` The figures below from the Palmaz patent show the Palmaz stent, as
`38.
`
`well as the balloon angioplasty catheter used to deliver the Palmaz-Schatz stent.
`
`As seen in Figures 3 and 4, this delivery system used retainer ring members 86 at
`
`the ends of the stent to secure the stent to the delivery system, as well as an
`
`optional Teflon sheath 89. (See Ex. 1008, Palmaz at 7:29-8:24.)
`
`- 21 -
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 24
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
`
`
`- 22 -
`
`
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 25
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
` By delivering a stent to the treatment location, and then expanding it
`39.
`
`to the desired diameter, the stent would provide structural support for a
`
`mechanically dilated vessel and “prevent[] the body passageway from collapsing
`
`and decreasing the size of the expanded lumen.” (Ex. 1008, Palmaz at 3:7-17
`
`(noting suitability of stents for use in “critical body passageways, such as the left
`
`main coronary artery of the heart”), 3:52-65.)
`
` As of 1996, the prior art taught the use of both self-expanding and
`40.
`
`balloon-expandable metal stents. (Id. at 7:44-62; Ex. 1017, Ravenscroft at 1:20-
`
`27.) As I noted above, I worked on an improved delivery system for the balloon-
`
`expandable stent developed by Drs. Palmaz and Schatz. Physician used both types
`
`of stent in conjunction with PTCA procedures, delivering them to the treatment site
`
`on delivery catheters. They differed primarily in their method of deployment. A
`
`physician typically deploys a self-expanding stent by retracting an enclosing
`
`sheath, thereby allowing the stent to expand to hold the arterial wall out to a pre-
`
`determined diameter. (See Ex. 14, Burton at 6:37-39, Fig. 1 (below).) To deploy a
`
`balloon-expandable stent, a physician uses the PTCA balloon to radially expand
`
`the stent to contact the arterial wall. (See Ex. 1015, Japanese Publication No. H4-
`
`64367 (“Olympus”) (“The stent is simultaneously expanded together with the
`
`balloon dilator.”).)
`
`- 23 -
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 26
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
`Self-expandable stent deployment: Burton Fig. 1
`
`
`
`
`
`Balloon-expandable stent deployment: Fischell ’274 Fig. 4
`
`
`
`2.
`Stent Delivery System Design Considerations
` Although they differed in deployment mechanisms, self-expanding
`41.
`
`and balloon-expandable stents shared many common design considerations. It was
`
`important that the delivery device have a small diameter or profile. This allows the
`
`stent to be delivered through a smaller entry incision and to pass more easily down
`
`the constrained arterial lumens. Both devices also had to be flexible so that they
`
`could navigate the sometimes tortuous arteries.
`
`- 24 -
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1003 - Page 27
`
`
`
`Petition for Inter Partes Review
`U.S. Patent No. 8,709,062
`
` Those skilled in the art also understood the shape of the delivery
`42.
`
`catheter was
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